Quality Of Evidence Research Articles

Obesity Management in Youth with Duchenne Muscular Dystrophy: A Review of Metformin and Alternative Pharmacotherapies.

Background: Individuals with Duchenne muscular dystrophy (DMD) have increased risk of obesity from prolonged glucocorticoid use and progressive muscle weakness. Over 50% have obesity by the teenage years. Objectives: The current study examines literature on obesity management in DMD and describes how obesity pharmacotherapy can be used in this high-risk cohort. Methods: This review was conducted in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A Pubmed Database search was conducted from January 2000 to May 2024. Included terms were DMD and topiramate, phentermine, metformin, glucagon-like peptide-1 receptor agonist, semaglutide, and liraglutide. Eligible studies were cataloged to examine obesity pharmacotherapy, side effect profiles, and clinical outcomes. Results: Twenty studies met inclusion criteria, 18 on metformin. Reviewed studies varied in duration from 4 to 24 weeks, ages 6.5-44 years old, with 112 participants total (range: 1-30 participants). Included studies were: eight animal studies, six clinical trials, four reviews, one cohort study, and one case report. Primary outcomes varied among studies: muscular degeneration and function (15 articles), cardiac function (2 articles), weight loss (2 articles), and general endocrine care (1 article). Conclusions: Adjunct obesity pharmacotherapy use in youth with DMD is promising but needs to be confirmed. Large gaps include appropriate agent selection, side effect monitoring, and dose escalation. The overall quality of pediatric-specific evidence for the use of obesity pharmacotherapy in youth with DMD is low. Future research is needed to investigate how to safely utilize these agents.

Novel β-lactam antibiotics versus other antibiotics for treatment of complicated urinary tract infections: a systematic review and meta-analysis.

Novel β-lactam antibiotics as well as other kinds of antibiotics have been used to treat complicated urinary tract infections (cUTIs); however, their efficacy and safety remain controversial. We conducted a systematic review with meta-analysis to explore the efficacy and safety of novel β-lactam antibiotics versus other antibiotics against cUTIs. PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched systematically from inception through 15 March 2024 for clinical trials comparing novel β-lactam antibiotics with other antibiotics for treatment of cUTIs. Random-effects models were used to evaluate the impact of treatment on the risk ratio (RR) of clinical response, microbiologic response, adverse effects (AEs), serious adverse effects (SAEs). The quality of evidence was evaluated with the Cochrane Risk of Bias assessment tool. The review was registered in INPLASY (INPLASY202440054). Ten randomized controlled trials involving 5, 925 patients met our inclusion criteria. Our meta-analysis revealed that there was no significant difference in overall clinical response (RR = 1.02), AEs (RR = 1.07), SAEs (RR = 1.20) between novel β-lactam antibiotics groups and other antibiotics groups. However, a significant difference was found in a subgroup of clinical cure rates at the end of treatment between novel β-lactam antibiotics groups and carbapenems groups, with low heterogeneity (RR = 1.02). A significant difference was observed in microbiologic response (RR = 1.11). Subgroup analysis revealed a significant difference in microbiologic response between novel BBL/BLS groups and carbapenems groups (RR = 1.13, I2 = 21%, P = 0.005). Differences was observed between novel BBL/BLS groups and piperacillin/tazobactam sodium groups (RR = 1.21, I2 = 70%, P = 0.02). Similar results were obtained from subgroup analysis of the difference in microbiologic response between novel β-lactam antibiotics groups and ertapenem groups (RR = 0.92, I2 = 0, P = 0.01). Novel β-lactam antibiotics had similar overall clinical cure, AEs, SAE, to other antibiotics in the treatment of cUTIs. However, novel β-lactam antibiotics demonstrated superior clinical cure rates compared to carbapenems in a subgroup analysis, and exhibited better microbiologic response than other antibiotics.

Association between intraoperative electroencephalogram burst suppression and postoperative delirium: A systematic review and meta-analysis.

Electroencephalogram burst suppression can be associated with postoperative delirium; however, the results of relevant studies are discrepant. This systematic review and meta-analysis aimed to assess the association between intraoperative burst suppression and postoperative delirium in adult surgical patients. PubMed, MEDLINE, Embase, Google Scholar, and the Cochrane Central Register of Controlled Trials were systematically searched and updated in May 2023. We included cohort studies, case-control studies, and randomized-controlled studies reporting on postoperative delirium incidence with documented intraoperative burst suppression in adults receiving general anesthesia for any surgery. The primary outcome was the pooled odds ratio (OR) for postoperative delirium in cases with intraoperative burst suppression compared to those without burst suppression, calculated using a random-effects model. Two independent investigators extracted the data. The protocol was prospectively registered in PROSPERO (registration number: CRD42022326479); the results were reported according to PRISMA guidelines. Fourteen studies (6435 patients) were included in the analysis. The overall incidence of postoperative delirium was 21.1% (1358/6435). Patients with intraoperative burst suppression had a higher incidence of postoperative delirium than those without burst suppression (pooled OR, 1.492; 95% confidence interval (CI) [1.022-2.178]; I2 =44%; 95% CI [0%-75%]; τ2 = 0.110). The intraoperative duration of burst suppression was significantly longer in patients who developed postoperative delirium (standardized mean difference [SMD] 0.462 [95% CI, 0.293-0.632]; I2 = 63%; 95% CI [16%-84%]; τ2 = 0.027). The burst suppression ratio was significantly higher in the delirium group (SMD 0.150; 95% CI [0.055-0.245]; I2 = 0%; 95% CI [0%-85%]; τ2 = 0.00). Our meta-analysis suggests an association between intraoperative burst suppression and postoperative delirium; however, the quality of evidence was very low. The limited number of studies and substantial heterogeneity across them emphasize the need for further high-quality studies to establish a more robust conclusion.

Does achieving apical patency increase postoperative pain during endodontics?

PubMed, Scopus, Embase, Web of Science, Cochrane Library, and gray literature up to May 2023. Twelve studies were included for meta-analysis. Two authors screened databases to identify suitable studies, with a third investigator resolving disagreements. Inclusion criteria were randomized controlled trials (RCTs) involving individuals without systemic diseases, who underwent root canal treatment in a permanent tooth with or without apical patency. Outcomes included pain, number of patients with pain and analgesic use. Exclusion criteria included patients who had undergone tooth extraction, incomplete data reports and studies which were not RCTs. There were no limits on publication language. A search of PubMed, Scopus, Embase, Web of Science, Cochrane Library, and gray literature from Google Scholar, ProQuest, OpenAire, and BASE identified 92 articles until May 2023. After removing 42 duplicates, 50 article full texts were assessed. Ultimately, 12 studies were included, seven of which were new relative to previous systematic reviews. Data were analysed using RevMan 5.4 software. Dichotomous categorical data were analysed through the Cochran-Mantel-Haenszel test, with the inverse variance method used for continuous data. Following assessment of heterogeneity with the χ2 test, fixed- or random- effects modeling was used. Pain scores were reported within one week by ten studies, but three were excluded from meta-analysis due to methodological issues. Studies involving participants aged 14-65 years, with pulp necrosis, apical periodontitis, or pulpitis, were included for analysis. Irrigation solutions varied from saline to sodium hypochlorite (2.25-5.25%), EDTA, citric acid, or chlorhexidine. Types of teeth treated included molars and anterior teeth. All studies used a 10# K-file for apical patency and various hand and nickel-titanium instruments for canal preparation. Generally, there was slightly reduced post-operative pain reported through the maintenance of patency. This was evident in the initial post-operative period of 24 h (OR = 1.69, P = 0.002), 1-day (MD = -1.69, P = 0.03) and 2-days (MD = -0.85, P = 0.04), but became non-significant over the remainder of the 7-day monitoring period. There was no significant difference in analgesic use between groups (OR = 0.82, P = 0.42). Studies were classified into three groups based on quality: four high quality with low risk of bias; three moderate quality with some concerns; and five low quality with high risk of bias. Evidence quality varied; pain scores on days 1 and 2 were of low quality, with very low quality for 12 h and days 3-6. High heterogeneity and imprecision were noted, especially in pain measurements and analgesic use. The meta-analysis indicates that during the initial post-operative period, apical patency significantly reduces postoperative pain. However, the findings should be interpreted cautiously due to high heterogeneity and variable evidence quality. Given that apical patency is seen as desirable for achieving the biological aims of endodontic treatment, the fact that it also appears to reduce post-operative pain helps to align patient reported outcome measures with traditional measures indicating success.

Prognostic and predictive factors in advanced upper gastrointestinal cancer treated with immune checkpoint inhibitors: a systematic review and meta-analysis of the current evidence

BackgroundImmune checkpoint inhibitors (ICIs) have shown encouraging treatment efficacy for upper gastrointestinal cancers (UGICs). However, durable clinical responses only existed in a minority of patients. We evaluated evidence predicting survival benefits to identify the optimal population followed by ICI-based therapy.MethodsA comprehensive search was performed using PubMed, Embase, Cochrane Library, and Web of Science to identify clinical trials for UGICs with ICI-based therapy. The outcomes were objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). The quality of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation System (GRADE).ResultsThirty-six studies comprising 12,440 patients were included for quantitative synthesis. Patients with PD-L1-positive (OR = 2.08, p < 0.00001), EBV+ (OR = 8.47, p = 0.003) tumors were more likely to respond to ICI treatment. Moreover, OS was significantly improved with the statistical subgroup difference concerning sex (p = 0.02) and region (p = 0.02). An exploratory subgroup analysis showed significantly improved OS with ICI plus chemotherapy in patients with CPS ≥ 10 (HR = 0.66, p = 0.001) and CPS ≥ 1 (HR = 0.75, p < 0.00001).ConclusionUGIC patients with PD-L1-positive, EBV + status are associated with a better therapeutic response to ICI-based therapy. The male patients and Asian patients could derive more survival benefits following ICI treatment than female and non-Asian ones. A combination of prognostic and predictive factors was suggested to help guide immunotherapy decision-making in UGIC patients.

Spontaneous space closure after extraction of permanent first molars in children and adolescents: a systematic review and meta-analysis.

Extraction of the permanent first molars is sometimes necessitated in children and adolescents due to deep carious lesions or developmental defects. To estimate the prevalence of spontaneous space closure after extraction of permanent first molars and identify factors associated with it. Unrestricted searches in five databases for human studies until February 2024. Longitudinal before-and-after (cohort) human studies assessing eruption of the permanent second molars and spontaneous space closure after extraction of the permanent first molar. Study selection, data extraction, and risk of bias assessment were performed in duplicate. Random-effects meta-analyses of average spontaneous space closure prevalences and odds ratios (OR) with their 95% confidence intervals (CI) were performed, followed by meta-regression/sensitivity/reporting biases' analyses and evaluation of our confidence in effect estimates. Sixteen reports pertaining to 15 studies (1 prospective /14 retrospective) were included covering 1159 patients (ages 5.5-15.0 years [mean 10.0 years]; 45% male on average) and 2310 permanent second molars. The prevalence of spontaneous space closure was higher in the maxilla (nine studies; 85.3%; 95% CI = 73.7%-92.3%) than the mandible (11 studies; 48.1%; 95% CI = 34.5%-62.0%) to a significant extent (nine studies; OR = 7.77; 95% CI = 4.99-12.11; P < 0.001). For both maxillary/mandibular second molars, Demirjian category E was associated with increased space closure odds than earlier/later stages (P < 0.05). Spontaneous space closure in the mandible was seen more often for patients ages 8-10 years (compared with older patients; three studies; OR = 3.32; 95% CI = 1.73-6.36; P < 0.001) and when the mandibular permanent third molar was present (four studies; OR = 2.28; 95% CI = 1.67-3.09; P = 0.003). Additional analyses failed to find any significant modifying factors. The quality of evidence was very low in all instances due to the inclusion of retrospective studies with methodological issues. Existing evidence indicates that spontaneous space closure in children and adolescents after extraction of the permanent first molar is seen more often in the maxilla than the mandible. Extraction of the permanent first molar at the Demirjian stage E of the second molar and presence of the lower permanent third molar is associated with increased odds of space closure, but uncertainty persists, due to methodological issues of existing studies. PROSPERO (CRD42023395371).

Effectiveness of rapid access chest pain clinics: a systematic review of patient outcomes and resource utilisation

BackgroundRapid Access Chest Pain Clinics (RACPC) are widely used for the outpatient assessment of chest pain, but there appears to be limited high-quality evidence justifying this model of care. This...

US FDA Advisory Panel Members’ Assessment of Premarket Approval Process and Suggestions for Improvement

The manufacturing and marketing of medical devices is regulated by the US Food and Drug Administration (FDA), and the FDA premarket approval (PMA) process evaluates the safety and effectiveness of medical devices. The PMA process includes a detailed scientific, regulatory and quality system review and is critical to ensure that novel devices are safe, effective, and meet the needs of patients. To survey current voting members serving on panels of the FDA's Medical Devices Advisory Committee to better characterize panel decision-making and identify steps for improvement. This qualitative survey study included 36 questions that were mailed to FDA device panelists regarding their opinions on the influence of sources of information, pivotal trial design, quality of evidence, panel composition and internal deliberative process, time allocation, and impartiality of the FDA. The survey was mailed to the members of all 18 FDA device panels in January and February 2017. Data were collected from January to May 2017 and analyzed from 2018 to 2019. Respondents read and returned the aforementioned paper survey, while nonrespondents did not. The main outcomes included panel members' perceptions, and their implications for process improvement. χ2 or Fisher exact tests were used to test differences between subgroups. Of 64 of 92 panel members who responded (69.6%), 38 of 64 (59.4%) were male, 3 of 63 (4.8%) were Black respondents, 46 of 63 (73.0%) were White respondents, and 36 of 60 (60.0%) were in academic practice. The mean (range) panel service was 6.8 (1-22) years with 3.9 (1-19) meetings attended. Overall, respondents considered information presented by the FDA unbiased, and 28 of 61 (45.9%) believed that pivotal trials were frequently well-designed, 55 of 62 respondents (88.7%) suggested FDA consult panel members preemptively regarding trial design and 54 of 64 (84.4%) regarding the device label. Most indicated that prior FDA approval of another device serving the same medical purpose (43 of 62 [69.4%]) or approval in other countries with comparable regulatory regimes, such as Canada and Europe (39 of 62 [62.9%]), would make them more likely to recommend approval. Respondents rated written information (50 of 60 [83.3%]), live presentations (43 of 58 [74.1%]), and prior professional knowledge (41 of 60 [68.3%]) as the most important sources of information in deciding whether to recommend approval. Additionally, 52 of 58 respondents (89.7%) recommended that a panel member-only executive session would allow more clarity and honesty in deliberations, and 33 of 59 (55.9%) believed a three-fourths majority appropriate for recommending approval, which would be a deviation from the current system in which an overall vote is reported without designation of a vote threshold. In this survey study of FDA device panel members, respondents wanted improved study designs, more relevant clinical data, including from other countries, involvement of panelists in study design and device label development, and inclusion of an executive session. Demographically, panels could be made more diverse.

Discontinuation of Cerebro-Spinal Fluid (CSF) Drainage in Acute Hydrocephalus: A Prospective Cohort Study and Exploratory Data Analysis.

The optimal management of CSF drainage in acute hydrocephalus, in particular when to initiate drain weaning, remains uncertain. This study aimed to evaluate the impact of timing and method of drain weaning on patient outcomes. This prospective observational study in a large-volume tertiary neuroscience centre included all adult patients who required temporary CSF drainage for acute hydrocephalus of any cause between January 2020 and March 2021. Contemporaneous data collection was conducted, including patient demographics, time to clamp, weaning methods, and clinical outcomes of hospital length of stay (LOS), rate of shunt insertion, drain-related infections, and mechanical complications. Univariate and multivariate statistical analyses were performed to identify the independent associations of timing-related factors. A total of 69 patients were included (mean age = 59.4 years). A total of 59% had CSF diversion for aneurysmal subarachnoid haemorrhage, and 88% had EVD drainage. The length of drainage prior to the first clamp was significantly associated with the overall length of drainage (p < 0.0001), LOS (p = 0.004), and time to shunt (p = 0.02) following multivariate adjustment. For each day delayed in initiating the drain challenge, the overall LOS increased by an additional 1.25 days. There was no association between the weaning method and LOS, the rate of shunting, or CNS infection; however, those in the gradually weaned group had more mechanical complications, such as drain blockage or CSF leakage, than those rapidly weaned (p = 0.03) after adjustment. This study recommends challenging the drain early via a rapid wean to reduce LOS, mechanical complications, and possibly infections. The consequences of temporary CSF diversion have significant implications at financial and patient levels, but the quality of evidence regarding weaning remains poor. Further randomised multicentre studies and national databases of practice are required to allow definitive conclusions to be drawn.

Passive smoking and risk of pancreatic cancer: an updated systematic review and meta-analysis.

Previous meta-analysis has demonstrated that no association was validated between passive smoking and pancreatic cancer. However, there is growing evidence on this issue recently. This study aimed to confirm this association. PubMed, Embase, Web of Science, and Cochrane Library databases were searched up to April 2024 for retrieval of full articles. Studies with the exposure of passive smoking and outcome of pancreatic cancer were eligible for the analysis. We generated pooled relative risks (RRs) and 95% confidence intervals (CIs) using DerSimonian-Laird random-effects models. Quality of evidence was assessed using the GRADE system. Fourteen studies were included, with 5,560 pancreatic cancer patients. Passive smoking was associated with a moderate increased risk of pancreatic cancer (RR = 1.20, 95% CI: 1.11-1.30, p<0.001). The results were consistent in both case-control (p=0.013) and cohort studies (p<0.001) and in studies with high (p=0.007) and moderate quality (p<0.001). In subgroup analysis, the risk was significant for both current (RR=1.91, 95% CI: 1.45-2.51, p<0.001) and non-current smokers (RR = 1.17, 95% CI: 1.01-1.36, p=0.037), for exposure both in adulthood (RR = 1.18, 95% CI: 1.06-1.31, p=0.002) and childhood (RR = 1.20, 95% CI: 1.08-1.34, p=0.001). However, only regular or daily exposure (RR=1.28, 95% CI: 1.08-1.50, p=0.003), rather than exposing occasionally, seldom or few times per week (p=0.421), to passive smoking could increase the risk of pancreatic cancer. Passive smoking exposure confers a significant increased risk for pancreatic cancer. The risk was valid in both case-control and cohort, high and moderate quality studies, in current and non-current smokers, and for both childhood and adulthood exposure. Regular or daily exposure rather than exposing occasionally, seldom or few times per week could exert a detrimental effect on pancreatic cancer.

The association between atopic dermatitis and linear growth in children- a systematic review.

To evaluate the association between atopic dermatitis (AD) and linear growth in children, and determine factors associated with compromised linear growth in children with AD. A PRISMA-compliant systematic review was conducted. Databases (PubMed, Embase, Scopus and Cochrane) were searched from inception to June 2024 for articles that reported a quantitative relationship between AD and linear growth in children (< 18years old). Quality of included articles was assessed using the Joanna Briggs Institute Critical Appraisal Tools while quality of evidence in these studies was evaluated using Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. Fourteen studies (comprising 50,146 patients with AD) were included. Seven studies reported a strong positive or positive association between AD and reduced height standard deviation score (SDS) in children; the others reported no association. Only 3 studies had moderate quality of evidence, all of which reported an association between AD and poorer height SDS; the remaining 11 studies scored low in quality of evidence. Three studies reported the impact of AD on height to be transient. Secondary analysis showed AD severity, earlier AD onset, sleep disruption and, food restriction, to be risk factors for linear growth impairment in patients with AD. Topical steroid use was not associated with shorter stature in patients with AD. Conclusion: Current evidence on the association between childhood AD and poor linear growth is weak and inconsistent. However, patients with more severe AD, earlier disease onset, poorer sleep quality and higher nutritional restrictions appear more susceptible to linear growth impairment. What is known? • There is inconsistent evidence of the association between atopic dermatitis (AD) and linear growth in children in current literature, with some studies suggesting that AD may negatively impact linear height while other studies do not report similar associations. What is new? • There is no strong association between AD in childhood and poorer linear growth. • There may be a transient slowing of linear growth in children with AD, mimicking constitutional growth delay. • Children with severe AD, earlier disease onset, poorer sleep quality and nutritional restrictions may be at risk of more significant linear growth impairment. • Topical steroid use does not appear to contribute to shorter height in children with AD.

What is the probability that higher versus lower quality of evidence represents true effects estimates?

The previous studies demonstrated that the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, a leading method for evaluating the certainty (quality) of scientific evidence (CoE), cannot reliably differentiate between various levels of CoE when the objective is to accurately assess the magnitude of the treatment effect. An estimated effect size is a function of multiple factors, including the true underlying treatment effect, biases, and other nonlinear factors that affect the estimate in different directions. We postulate that non-weighted, simple linear tallying can provide more accurate estimates of the probability of a true estimate of treatment effects as a function of CoE. We reasoned that stable treatment effect estimates over time indicate truthfulness. We compared odds ratios (ORs) from meta-analyses (MAs) before and after updates, hypothesising that a ratio of odds ratios (ROR) equal to 1 will be more commonly observed in higher versus lower CoE. We used a subset of a previously analysed data set consisting of 82 Cochrane pairs of MAs in which CoE has not changed with the updated MA. If the linear model is valid, we would expect a decrease in the number of ROR = 1 cases as we move from high to moderate, low, and very low CoE. We found a linear relationship between the probability of a potentially 'true' estimate of treatment effects as a function of CoE (assuming a 10% ROR error margin) (R2 = 1; p = 0.001). The probability of potentially 'true' estimates decreases by 21% (95% CI: 18%-24%) for each drop in the rating of CoE. A linear relationship with a 5% ROR error margin was less clear, likely due to a smaller sample size. Still, higher CoE showed a significantly greater probability of 'true' effects (53%) compared to non-high (i.e., moderate, low, or very low) CoE (25%); p = 0.032. This study confirmed linear relationship between CoE and the probability of potentially 'true' estimates. We found that the probability of potentially "true" estimates decreases by about 20% for each drop in CoE (from about 80% for high to 55% for moderate to 35% to low and 15% to very low CoE).

Research Review: Pharmacological and non-pharmacological treatments for adolescents with attention deficit/hyperactivity disorder - a systematic review of the literature.

Attention Deficit/Hyperactivity Disorder (ADHD) demonstrates unique developmental manifestations in adolescence with implications for optimized, age-appropriate treatment. This 10-year update is the third in a series of systematic reviews examining the efficacy and safety of adolescent ADHD treatments. We broadly examined efficacy on ADHD symptoms, impairments, and other reported outcomes. Acute and long-term efficacy, and treatment moderators, were considered. We performed PubMed, EMBASE, and PsycINFO searches for articles published or in press from 2013 to 2024, integrated with hand search and randomized controlled trials (RCTs) identified in this series' earlier reviews. RCTs examining the safety or efficacy of interventions delivered to adolescents (ages 10.0-19.9) with a diagnosis of ADHD were included. Study characteristics were extracted and reviewed, quality of evidence was assessed using GRADE, and effect sizes were calculated for individual studies and illustrated using forest plots. Sixty-three RCTs were identified. Quality of evidence ranged from high (medication; k = 29) to very low (nutrient supplementation, neurofeedback, occupational therapy; k = 1 each). Medications demonstrated consistent strong impact on ADHD symptoms and inconsistent impact on impairment. Diverse cognitive/behavioral treatments (C/BTs) demonstrated inconsistent impact on ADHD symptoms but strong and consistent impact on impairment and executive function skills, plus moderate benefits on internalizing symptoms. No interventions demonstrated significant safety concerns. Long-term maintenance (up to 3 years post-treatment) was demonstrated for C/BTs, though moderate quality of evidence was noted because participants cannot be fully blinded to receipt of treatment. The effects of C/BTs and medication appear complementary, not duplicative. Combining medication and C/BT is advised at treatment outset to maximize engagement, maintenance, and response breadth (i.e. improving both ADHD symptoms/cognitive performance and coping skills/functional impairments). Engagement strategies (e.g. motivational interviewing) may facilitate uptake. Novel treatments do not yet demonstrate effects on ADHD symptoms or impairments in adolescents but remain a promising area for research.

Taking an argumentation approach to statistical investigations: developing student data-ing practices

AbstractResearch literature has provided considerable insight as to how young students might come to deeper understandings of statistical concepts, processes and representations through investigations. However, ‘data-ing’—the critical thinking aspects of decision-making while engaging in statistical investigations—has shown to be more difficult to grasp. Data-ing aspects of statistical investigations identified in literature as particularly challenging include: generating researchable questions, knowing when or how to apply statistical knowledge, seeing a need for evidence to support conclusions, and knowing how to use data as evidence. Argumentation practices necessitate a focus on the use of evidence to logically support a claim, thereby offering potential to focus students on the sufficiency and quality of evidence and the conclusions that can be drawn. As such, argumentation offers potential to support students to engage in data decision-making practices. In the research described here, an argumentation focus was used to guide a statistical investigation with a class of 9–10-year-old students in a suburban Australian school. Analysis of classroom interactions and children's work samples suggested that taking an argument-based focus supported students’ developing capacity to overcome the aforementioned challenges and to engage in critical, decision-making practices with authentic, messy data within the context of the investigation.

Insights and networks: methodological assessment and scientometric analysis of economic evaluations in dentistry

IntroductionAssessing the methodological quality of economic evaluations (EEs) is crucial for evidence-based decision-making. The study aimed to evaluate EEs in restorative dentistry and endodontics, while also analyzing the scientific landscape of researchers and publications through co-authorship and citation network analysis providing an insight into the distribution of scientific expertise.MethodologyA systematic search for relevant articles from 2012 to 2022 was conducted using PubMed, Scopus, and EBSCO. The ten-point Drummond checklist was used to appraise the methodological quality of included studies. Bibliometric data for network analysis were extracted from the Dimensions database and visualized using VOSviewer software.ResultsOf the 37 articles, 81.08% scored good, 16.21% average, and 2.7% poor on the methodological rating scale. Most of the included studies were in Q1 journals, with limited representation in Q2 and Q3 journals. Compliance was highest in Q2 journals (95%), followed by Q1 (88.36%), while it dropped to 40% for Q3 journals. Co-authorship analysis revealed a dense network of researchers, with Prof. Falk Schwendicke V. having a significant influence. Moreover, the Journal of Dentistry had the highest impact, followed by Journal of Endodontics and BMC Oral Health.ConclusionsDespite a diverse scientific landscape, participation from developing countries was limited emphasizing the need for inclusivity and diversity in the scientific network. While the quantity of good-quality studies was encouraging, the overall quality of evidence remains paramount for decision-making in healthcare policy and practice. Therefore, continuous efforts to improve methodological rigor and reporting practices are essential to contribute robust evidence.

Patient-Reported Outcome Measures for Pelvic Organ Prolapse: A Systematic Review Using the COnsensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) Checklist.

Patient-reported outcome measures (PROMs) are recommended to measure the impact of a health condition or intervention effectiveness as they aim to capture what is most meaningful to patients. Several PROMs are used to evaluate pelvic organ prolapse (POP)-related domains, yet the measurement properties of these instruments have not been fully explored with a rigorous analysis of the methodological quality and quality of evidence. To conduct a systematic review reporting on the measurement properties of PROMs used for the assessment of POP-related domains in accordance with the COSMIN guidelines. Five databases were searched from inception to December 2023. Studies were eligible if they involved (1) at least one group of female adults diagnosed with or presenting with symptoms of POP; (2) a self-reported outcome measure (PROMs, questionnaires) to evaluate POP-related domains; and (3) at least one measurement property. Methodological quality and measurement quality were assessed using the COSMIN risk of bias (ROB) checklist and the COSMIN criteria for good measurement properties. A total of 13 PROMs were included. The BIPOP had the lowest ROB for Content Validity. The POP-SS was the only PROM with sufficient evidence of adequate construct validity and responsiveness to be used in both surgical and conservative management settings. This original work identified a gap in evidence regarding the measurement qualities of identified PROMs used in the POP population.

Effectiveness of osteopathic craniosacral techniques: a meta-analysis.

Craniosacral osteopathic manipulative medicine-also known as craniosacral therapy (CST)-is a widely taught and used component of osteopathic medicine. This paper seeks to systematically review and conduct a meta-analysis of randomized controlled trials assessing the clinical effectiveness of CST compared to standard care, sham treatment, or no treatment in adults and children. A search of Embase, PubMed, and Scopus was conducted on 10/29/2023 and updated on 5/8/2024. There was no restriction placed on the date of publication. A Google Scholar search was conducted to capture grey literature. Backward citation searching was also implemented. All randomized controlled trials employing CST for any clinical outcome were included. Studies not available in English as well as studies that did not report adequate data were excluded. Multiple reviewers were used to assess for inclusions, disagreements were settled by consensus. PRISMA guidelines were followed in the reporting of this meta-analysis. Cochrane's Risk of Bias 2 tool was used to assess for risk of bias. All data were extracted by multiple independent observers. Effect sizes were calculated using a Hedge's G value (standardized mean difference) and aggregated using random effects models. The GRADE system was used to assess quality of evidence. The primary study outcome was the effectiveness of CST for selected outcomes as applied to non-healthy adults or children and measured by standardized mean difference effect size. Twenty-four RCTs were included in the final meta-analysis with a total of 1,613 participants. When subgroup analyses were performed by primary outcome only, no significant effects were found. When secondary outcomes were included in subgroup analyses, results showed that only Neonate health, structure (g = 0.66, 95% CI [0.30; 1.02], Prediction Interval [-0.73; 2.05]) and Pain, chronic somatic (g = 0.34, 95% CI [0.18; 0.50], Prediction Interval [-0.41; 1.09]) show reliable, statistically significant effect. However, these should not be interpreted as positive results as wide prediction intervals, high bias, and statistical limitations temper the real-world implications of this finding. CST demonstrated no significant effects in this meta-analysis, indicating a lack of usefulness in patient care for any of the studied indications.Pre-registration available at https://doi.org/10.17605/OSF.IO/54K6G. https://osf.io/57t4w.

Efficacy of pelvic floor muscle training with physical therapy for low back pain: A systematic review and meta-analysis

Objective To assess the efficacy of pelvic floor muscle training and physical therapy interventions in patients with low back pain. Data sources The Ovid–Medline, Ovid–Embase, Cochrane Library, CINAHL, Web of Science, and PEDro databases were searched for randomised, controlled trials published in English or Korean between database inception and September 2024. Review Methods Studies providing pelvic floor muscle training in individuals with low back pain were included. The risk of bias using the Cochrane Risk of Bias 2 tool and the grading of recommendation, assessment, development, and evaluation (GRADE) system was used to evaluate the quality of evidence. The meta-analysis was performed using Review Manager software 5.4. Results Nineteen studies were included in this review. Pelvic floor muscle training showed low certainty evidence for improving pain (standardised mean difference = −0.73, 95% CI [−1.10, −0.36]) and reflected a clinically meaningful reduction in pain. The evidence for disability improvement had a low certainty (mean difference = −5.21, 95% CI [−7.15, −3.26]) due to high heterogeneity. Substantial improvements in pain and disability were observed when pelvic floor muscle training was added to standard physical therapy, with low certainty of evidence supporting these findings. Whereas pelvic floor muscle training substantially improved pain compared to other interventions, there was no marked improvement in disability. Conclusion Pelvic floor muscle training is potentially beneficial in addition to physical therapy for reducing low back pain, particularly in pregnancy-related cases. However, the evidence should be interpreted considering the quality and risk of bias.

Surgical management of obstructing ureteral stones during pregnancy: A systematic review of different techniques.

Renal colic is the most common non-obstetric cause of abdominal pain during pregnancy and is associated with a higher risk of complications in these women. When invasive treatment is required, options are temporary drainage with ureteral stent (JJ) or percutaneous nephrostomy (PCN), or immediate definitive treatment with ureteroscopy (URS). Our goal was to review the safety and efficacy of these procedures in treating urolithiasis during pregnancy. Adhering to the PRISMA checklist guidelines, we searched PubMed, Embase, and Scopus databases for articles on the efficacy and complications of the three procedures in pregnant women. The quality of evidence and risk of bias were evaluated using the Critical Appraisal Skills Programme and the Institute of Health Economics tools. We included 45 articles, totaling 3424 interventions in pregnant women - 2188 URS, 719 JJ, and 517 PCN. URS was the most assessed procedure, with stone-free rates comparable to the non-pregnant patients. The most frequent complications were lower urinary symptoms and infections independently of the intervention. Obstetric complications for all interventions included 167 cases of preterm labor, resulting in 24 premature births. No statistically significant differences in post-operative complications were reported between the procedures in the few comparative studies. Despite the absence of high-quality studies, current evidence suggests that URS, JJ, and PCN are all safe and effective during pregnancy. As most patients submitted to temporary drainage require a second procedure post-delivery, primary URS appears more efficient. Therefore, it is the preferred option unless there are indications for temporary drainage.

Acupuncture treatment of diabetic peripheral neuropathy: an overview of systematic reviews based on evidence mapping.

The study attempted to evaluate the meta-analyses (MAs) of the acupuncture treatment of diabetic peripheral neuropathy (DPN) to provide a basis for clinical decision-making. Eight databases, such as PubMed, Cochrane Library, Embase, Web of Science, CNKI, Wanfang Data, CQVIP, and CBM, were searched from database creation to December 22, 2023. The MAs of DPN treatment using acupuncture or acupuncture combined with conventional Western medicine were included. AMSTAR-2 and PRISMA 2020 helped evaluate the methodological and reporting quality of the included studies. The GRADE methodology helped assess the evidence quality of outcome indicators. Evidence mapping was performed to display evaluation results. A total of 18 MAs involving 23,240 DPN patients were included. Based on the methodological quality evaluation, four MAs were of "moderate" quality, seven had a quality grade of "low," and another seven were of "critically low" quality. The evidence quality evaluation showed that among studies of acupuncture vs. conventional Western medicine, four had an evidence quality of "moderate," 18 had an evidence quality of "low," and 17 had an evidence quality of "critically low" and that among studies of acupuncture + conventional Western medicine vs. conventional Western medicine, 12 had an evidence quality of "moderate," 29 had an evidence quality of "low," and 33 had an evidence quality of "critically low." Compared with conventional Western medicine, simple acupuncture and acupuncture + conventional Western medicine significantly improved total effective rate (TER) and nerve conduction velocity (NCV). Acupuncture treatment of DPN significantly improves TER and NCV with proven safety. However, the MAs of the acupuncture treatment of DPN must strictly refer to relevant standards and specifications regarding methodological and reporting quality, along with the design, execution, and reporting of primary randomized controlled trials (RCTs).